510(k) K780135

CEMENT EXTRACTION INSTRUMENT SET by Orthopedic Equipment Co., Inc. — Product Code KDG

K780135 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "CEMENT EXTRACTION INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on January 31, 1978. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.